What is a challenge of value-based pharmaceuticals and tiered formularies?

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Linking pay for drugs to their outcomes and using tiered formularies are meant to align reimbursement with value, but the big challenge lies in measuring what counts as value and making sure patients can actually access those therapies. Measuring value requires robust, real-world data on how well a drug works, how it affects quality of life, and what it costs over time. Different stakeholders may value different outcomes, and value can vary across patient subgroups, age, comorbidities, and adherence patterns. Determining an appropriate horizon for benefits, selecting consistent metrics, and agreeing on acceptable cost-effectiveness thresholds or risk-sharing arrangements add layers of complexity. On the access side, even a therapy deemed valuable may become harder to obtain if it sits in a higher formulary tier with larger copays, if prior authorization delays occur, or if administrative and data-sharing requirements slow patient uptake. These realities mean that, despite the intent to improve care and control costs, both measuring value and ensuring equitable patient access remain key challenges.